Rational drug therapy device and methods

Abstract

A method and a system for treating vascular in-stent restenosis that combines two disparate drug delivery systems wherein the two drug systems act in a synergistic fashion to produce maximal therapeutic benefit at a targeted site. Controlled delivery of non-toxic, subthreshold doses of a systemic drug is combined with the localized delivery of a second drug via catheter-mediated stent placement to provide therapeutic benefit. Because each drug acts independently via distinct yet related molecular pathways, full therapeutic benefit can be designed as additives and occurs only at the targeted site.

What is claimed is:  
     
         1 . A drug delivery system for delivering drugs to a localized site comprising: 
 a first drug; and    a second drug, wherein said first drug and said second drug act synergistically at said localized site.    
     
     
         2 . The drug delivery system of  claim 1  wherein said first drug is a systemically delivered drug.  
     
     
         3 . The drug delivery system of  claim 2  wherein said systemically delivered drug is administered orally, sublingually, intravenously, intraocularly, intramuscularly, intracranially, peritoneally, transdermally, vaginally, rectally, by insufflation, by inhalation, or by catheterization.  
     
     
         4 . The drug delivery system of  claim 2  wherein said first drug is selected from the group consisting of a phosphodiesterase inhibitor, a superoxide dismutase, an anti-inflammatory compound, or an anti-oxidant.  
     
     
         5 . The drug delivery system of  claim 1  wherein said second drug is a locally delivered drug.  
     
     
         6 . The drug delivery system of  claim 5  wherein said second drug is nitric oxide or a gene encoding nitric oxide synthase.  
     
     
         7 . The drug delivery system of  claim 5  wherein said second drug is locally delivered by a stent.  
     
     
         8 . A drug delivery system for delivering drugs to a localized site comprising: 
 a systemically delivered drug; and    a locally delivered drug, wherein said systemically delivered drug and said locally delivered drug act synergistically at a site of local delivery.    
     
     
         9 . The drug delivery system of  claim 8  wherein said systemically delivered drug is administered orally, sublingually, intravenously, intraocularly, intramuscularly, intracranially, peritoneally, transdermally, vaginally, rectally, by insufflation, by inhalation, or by catheterization.  
     
     
         10 . The drug delivery system of  claim 8 , wherein said systemically delivered drug is selected from the group consisting of a phosphodiesterase inhibitor, a superoxide dismutase, an anti-inflammatory compound, or an anti-oxidant.  
     
     
         11 . The drug delivery system of  claim 10 , wherein said locally delivered drug is delivered by a stent.  
     
     
         12 . The drug delivery system of  claim 11 , wherein said locally delivered drug is nitric oxide, a gene encoding nitric oxide synthase, superoxide dismutase, an anti-inflammatory compound, or an anti-oxidant.  
     
     
         13 . A method of delivering a drug to an affected site comprising: 
 delivering a first drug to an affected site; and    administering a second drug, wherein said first drug and said second drug act synergistically at said affected site.    
     
     
         14 . The method of  claim 13  wherein said first drug is delivered to said affected site by a stent.  
     
     
         15 . The method of  claim 14  wherein said first drug is nitric oxide or a gene encoding nitric oxide synthase.  
     
     
         16 . The method of  claim 13  wherein said second drug is administered orally, sublingually, intravenously, intraocularly, intramuscularly, intracranially, peritoneally, transdermally, vaginally, rectally, by insufflation, by inhalation, or by catheterization.  
     
     
         17 . The method of  claim 13  wherein said second drug is selected from the group consisting of a phosphodiesterase inhibitor, a superoxide dismutase, an anti-inflammatory compound, or an anti-oxidant.  
     
     
         18 . A drug delivery system for delivering drugs to a localized site comprising: 
 a medical device having a metallic surface, said metallic surface having nitric oxide releasably bound thereto; and    a systemically delivered drug.    
     
     
         19 . The drug delivery system of  18  wherein said medical device is selected from the group consisting of stents, guide wires, catheters, trocar needles, bone anchors, bone screws, protective platings, hip and joint implants, electrical leads, biosensors and probes.  
     
     
         20 . The drug delivery system of  18  wherein said systemically delivered drug is administered orally, sublingually, intravenously, intraocularly, intramuscularly, intracranially, peritoneally, transdermally, vaginally, rectally, by insufflation, by inhalation, or by catheterization.  
     
     
         21 . The drug delivery system of  18 , wherein said systemically delivered drug is selected from the group consisting of a phosphodiesterase inhibitor, a superoxide dismutase, an anti-inflammatory compound, or an anti-oxidant.